Bone compression screw

ABSTRACT

A system for orthopedic repair of bones, the system may include a compression screw. The screw may include a blunt tip on one end with tapped threads to allow for greater bone fixation uniform across a threaded portion of the screw. The screw may also include springs, which may be Belleville washers, which provide appropriate compression and tension and prevent excessive loosening of the screw after surgery. The springs allow the screw to retract without losing pressure on the fracture site. The system may be minimally invasive for multiple fractures on a single bone such as calcaneal fractures, and stabilizing long bone fractures without bone plates.

CROSS-REFERENCE TO RELATED APPLICATIONS

The present application is a continuation of

U.S. patent application Ser. No. 13/793,865, Attorney's Docket No.BRI-1, entitled BONE COMPRESSION SCREW, which was filed on Mar. 11,2013.

The foregoing is incorporated by reference as though set forth herein inits entirety.

This application incorporates by reference the following applications intheir entirety:

U.S. Patent Application 61/436,160, filed Jan. 25, 2011, entitled BONESCREW SUSTAINING OSTEOTOMY SITE-STABILIZING COMPRESSIVE FORCE,HOSPITABLE TO OSTEOCLASTIC FORMATION, DYAMICALLY FOR MONTHS;

U.S. Patent Application 61/479,111, filed Apr. 26, 2011, entitledWIRE-SPRING-CABLES AND A CALCANEOUS SCREW SUSTAINING OSTEOTOMYSITE-STABILIZING COMPRESSIVE FORCE, HOSPITABLE TO OSTEOCLASTICFORMATION, DYAMICALLY FOR MONTHS;

U.S. Patent Application 61/485,319, filed May 12, 2011, entitled BONESCREW AND CABLE CONNECTIONS SUSTAINING OSTEOTOMY SITE-STABILIZINGCOMPRESSIVE FORCE, HOSPITABLE TO OSTEOCLASTIC FORMATION, DYAMICALLY FORMONTHS; and

U.S. Patent Application 61/509,004, filed Jul. 18, 2011, entitledMEDICAL APPARATUS, attorney docket number 2924.2.4p.

BACKGROUND

The current disclosure is intended to document further improvementsdiscovered subsequent to submission of provisional patent requests61/436,160, 61/479,111, 61/485,319 and US 61/509,004 which are allherein incorporated by references. Specifically, modifications disclosedherein include a screw head, of approximately the same size as screwheads in the current art, and transferring load from Belleville stylespring washers used as spring elements in bone screws. Bone screws asdisclosed herein may be fabricated without self-tapping sharp tips.Installation tapping bits can be used to create gaps on the engaged sideof threads, such that in the fully tensioned or compressed state, thescrew threads engage the bone more uniformly.

The process of bone fixation includes reapproximating two osseousstructures and then holding them together while bone healing takesplace. However, within 2 to 24 hours after bone surgery, screwsinstalled to hold fractured bone together loosen significantly.

Often, loose screws will back out of the bone, causing soft tissueirritation. With significant loosening, bone fragments become subject tomovement at the facture site. This movement creates many problems duringthe healing process including further injury, prolonged healing,nonunion and/or an inappropriate union. These disadvantages often causerecommendation for prolonged non-weight bearing, with pain and withpotential for abuse of pain medication. The risks of prolongednon-weight bearing are Deep Vein Thrombosis (DVT's), osteopenia changes,muscle atrophy, joint ankylosis and generalized soft tissue contracturesincluding ligaments, tendons and neurovascular bundles. Depending on thepatient and the time frame that non-weight bearing is necessary, some ofthe aforementioned risks may be non-reversible resulting in chronicmorbidity.

Studies have shown that by increasing weight bearing earlier, there isnot only a significant reduction in the chronic morbidities listedabove, but there is also an increase in functionality and an earlierreturn to activities. The complications with early weight bearing arethe possibility of current hardware failure and fatigue, fracturefragments shifting due to inadequate compression or non-anatomicfixation, and non-unions stemming from either an avascular compromise ormicromotion in a seemingly anatomic correction.

The goal of a dynamic compression screw is to allow continuedcompression that can withstand the forces of early protected weightbearing. This would reduce a substantial amount of physician bills andinsurance payouts that can occur due to complications and lostemployment.

Screws are routinely installed with the self-tapping, sharp and pointedtip extending beyond the far outside bone surface, into the softtissues. The disclosed bone hole that is tapped for screw installation,by the conventional screw thread tip, has negative value. The screw tipsused to be very dull and not as pointed until the older art and industrystandard was altered in an attempt to be self-tapping and thereby speedup the surgical process. Screws now have a bone cutting tip that isusually trocar in nature and very sharp in an attempt to reduce thetapping step. The problem is that the pointed and sharp screws need tobe installed with their threads typically extending 2-3 threads beyondthe cortex, i.e., into soft tissues. But doing so leaves a sharp knifelike object that is exposed outside the bone in soft tissues. Thisexposed object can create trauma to surrounding tendons, ligaments, boneperiosteum and can increase long term post-operative pain.

Finite Element Analysis (FEA) and experimental observations have shownthat the highest screw pullout stresses occurred at the upper threadlocation. Research suggests screws stretch significantly when loaded intension or shorten when loaded under compression. Either conditionaccumulates strain toward an end where the maximum strain concentratesstress at the last single screw thread in the bone. The traditionalresult is the potential for a progressive failure mode wherein a failedthread transfers the highest strain and stress to end threads, whichin-turn may overstress bone. Overstressed bone results in microscopicfatigue. The body reacts by resorption causing screw loosening attypical installation loads. The resorption continues down the thread,effectively shearing the screw loose from the bone. Full screw thread tobone engagement is not achieved in the current art. The disclosed devicesuggests pre-tapping and overdrilling the hole, as mentioned above, andeliminating the sharp cutting tip.

Further, the present device, may also integrate a Belleville washersingle spring, stacked spring or reversing stacked spring section intothe head of the screws to enable load bearing on the relatively thin butstrong cortical bone. This enables the screws to retract and continue toprovide the necessary pressure on the bone to hold fracture sitestogether, secured against movement from internal and external forces,and under compression specific to promoting bone growth. This increasesrates at which the bone will heal, decreases soft tissue damage fromtraditional screw lifting, and prevents additional injury, delayedunion, nonunion, and/or inappropriate union. Using these improvements tothe current art, fixation can more frequently be done internally,eliminating a source for pin-tract infection risk from external fixationand substantially reducing the complications mentioned above.

Previously engineered dynamic screws are inadequate. Otherconfigurations are simply not structurally capable of producing thetension necessary to hold the bones together at the fracture site, aretoo rigid to provide sufficient retraction during the loosening phase ofhealing, or both.

Without these spring screws, animals are often euthanized as the onlyhumane option, and people spend a lot of time in various types ofrecovery that will no longer be necessary. These new dynamic bone screwsenable internal fixation of fractures or osteotomy sites. Internalfixation can improve by closing the fracture zone gap that naturallyoccurs during healing, and maintain consistent rigid fixation. Theproposed screws do not loosen, but relax, stabilizing the joint whileallowing earlier movement and weight bearing to stimulate bonegrowth—reducing net healing time. Traditional head lifting iseliminated, with its attendant soft tissue irritation, screw breakageand the need for surgical removal or retightening. An osteotomy orfracture under the resulting dynamic stabilizing forces, allows early,often immediate motion and weight bearing, as tolerated, resulting insignificantly earlier rehabilitation and return to normal activity.

The devices herein disclosed would allow for minimally invasiveprocedures while allowing patients a quicker return to activity withpotential weight bearing immediately after surgery as tolerated, withoutincreasing the risk of nonunion. An earlier return to normal activityand less frustration for patients and their doctors is expected with thedevice. For a veterinarian, repairing a complex leg fracture on a horse,the ability to achieve weight bearing immediately or very soon afterinternal fixation surgery can be the difference between life and deathfor the animal.

The spring screws and cable connections disclosed herein, are mentionedin provisional patents incorporated herein by reference 61/436,160;61/479,111; 61/485,319; and US 61/509,004; and contain very small, butstrong, nested, stiff springs, designed to perform dynamically duringinternally and externally applied forces and following bone retraction,from healing and from screw bearing-induced bone retraction. The screwsand cables are thereby capable of sustained delivery of the level ofbone compression sufficient to trigger bone growth and resist internaland external forces while contracting to accommodate the live bonereaction to internal fixation. The devices disclosed herein can retainpressure in a very specific range of bone stresses necessary to triggerbone growth, avoid progressive fissuring from stress concentrationsabove yield, and avoid stress shielding of the bone.

Creating a blunt screw tip, as suggested in the incorporated provisionalapplications, can fully engage bone with the full shank of threads. Thisenables the screw to grab the far cortex after drilling through the nearcortex, adhering to the cortical rim while compression takes place. Thisconstitutes a new advancement in the art.

When an osteotomy or fracture is reduced for fixation, whether naturalor cut, at the micro scale, the bone-bone interface only actuallytouches initially at a few small contact points. Screw landings andthreads also initially bear on the bone only at small contact points.These small initial contact points, in the fracture zone, below landingsand on top of screw threads are locally highly stressed by hardware thatis producing compression in the osteotomy. The contact points fissureand are soon resorbed by the body. Early resorption also results inprogressive diminution of the fracture gap. Diminution is the gradual (2to 24 hours) reduction in the physical dimension between cut or fracturesurfaces during the natural healing process. Tension in rigid hardware(used to create compression in an osteotomy or natural fracture) isreduced by diminution of the cut or natural fracture gap. An orthopedicscrew, installed through a fractured joint, stretches a few microns whenit is tightened to a specified torque. When diminution occurs in thejoint, the stretching relaxes and the installed force of tension in thescrew is correspondingly relaxed. Further relaxation of hardware mayresult from continued fissuring and resorption of small contact pointsunder landings and on top of threads bearing on bone. This fissuringdiminution may continue until a more uniformly distributed stress atbone to bone contact points and on head & thread to bone contact areasachieve a net bone yield stress levels of 60 N/mm² or below, seating thejoint and hardware. With conventional hardware, tension in the screwdrops quickly, because the screws are stiff.

By integrating a spring-like section into screws and cables, proposedherein, the hardware will retract and continue to provide the necessarypressure on the bone for diminution and seating to complete whilecontinuing to hold fracture sites together under compression. Internalfixation, using such spring loaded hardware, is secured against movementfrom internal and external forces, and can be optimized to sustaincompression specific to promoting bone growth. It is disclosed that thismay enable bone bridging, increasing rates at which the bone will heal,decrease soft tissue damage from traditional screw lifting, and preventadditional injury, delayed union, nonunion, and/or malunion. Using suchdynamic hardware, fixation can more frequently be done internally,eliminating external fixation sources for pin-tract infection.

It is herein postulated that achieving a more uniformly distributedstress distribution between threads and bone could achieve a net higherpullout value and quickly seat the hardware at bone yield stress levelsbelow 60 N/mm², above which natural fissuring and resorption wouldotherwise continue to occur. By limiting bone fissuring and resorptionon active bearing thread surfaces, less spring action will be requiredto maintain a tight, functional screw.

The device more efficiently utilizes the cross section of the purchasedbone, and delivers a significantly higher level of compression, reliablysustained within the desired range to promote bone growth throughout thenatural bone retraction that occurs during the healing process followingfixation which the current art fails to accomplish. Existing competitivescrews have sharp, pointed tips whereas the disclosed device may notinclude sharp, pointed tips.

Installation tapping bits can create gradually tapered gaps in theactive engagement zone, e.g., on tension screws, above threads, suchthat in the fully tensioned state, the screw threads engage the bonemore uniformly. By matching fully stressed screw dimensions with thepre-threaded gap used to install it, the threads more uniformly engagethe bone, yielding a substantially increased pullout value.

SUMMARY

A system may include a body with a shaft between proximal and distalends. The proximal portion may include a base and a head with springsbetween them. The base and head may have larger diameters than the shaftitself and the base may have a bone engaging surface to engage a portionof a bone. In addition both the base and head may have spring engagingportions to interact or engage the springs between them. The system mayinclude some or all of the following features of threads extendingradially from the distal portion and a blunt distal tip. Other featuresmay include bores or apertures passing centrally through each of thebase, the head and the springs. The apertures may allow the componentsof the head, base and springs to slidably engage the shaft. The springsmay be Belleville washers and there may be one or multiple Bellevillewashers and all the Belleville washers may face a single direction. Thehead may also include threads to engage a proximal end of the body, thehead also including a polygonal shape to engage an insertion orinstallation tool.

Another embodiment of the system may include first and second portionseach comprising shafts with proximal and distal portions. Each of thefirst and second portions may also include a head and a base. The firstportion head and base may include springs between them with springengaging surfaces on both the base and head. The second portion mayinclude an intermediate component and springs between the base and theintermediate component with both the base of the second portion and theintermediate component including spring engaging surfaces. The head ofthe second portion may be positioned proximate to the intermediateportion. In this alternate embodiment, there may be a rod engaged withboth the first and second portions and positioned between them. Otherfeatures of the alternate system may include threads on intermediatecomponent and the bases include a central aperture that may be threadedand engages threads on the first and second shafts respectively. Thesprings that are spaced between the components referenced may be aBelleville washer or multiple Belleville washers and those washers mayall face the same direction or they may face different directions. Theheads in both the first and second portions may be hexagonal in shapeand may engage first and second proximal ends of the first and secondshafts respectively.

One method of assembling the devices disclosed above is to slide a baseonto a shaft, or screw from the proximal end of the shaft because thedistal end includes a threaded portion with threads extending radiallyfrom the shaft that are too large for the aperture of the base to passover. Springs may then slide onto the shaft, after the base, and slidefreely along the shaft in a manner similar to the base, the springs alsoincluding an aperture large enough to slide from a proximal end, but notthe distal end of the shaft. Finally positioning a head proximal thesprings and the base and either engaging the shaft through threading,press fit, snap fit or other means. The springs include at least oneBelleville washer which engages the base and the head. The distal end ofthe shaft may include recessed threads to engage the head in a threadingmanner listed above to prevent the springs and base from being removedfrom the shaft. Although press-fitting, welding or snap-fitting, withthe absence of threads, may also be another means to prevent withdrawalof the base and springs from the shaft.

The disclosed device proposes configuring spring washers into screws andcable connections to deliver the compressive force necessary to promotebone growth while retracting to close the gap(s) and continuecompressive force, with flexibility to resist internal and externalforces that may otherwise cause movement in the joint. The disclosedspring configurations also avoid unbalanced internal stiffness problemsthat could otherwise result in progressive or fatigue failure undercyclic loading. Additionally a radio frequency controlled strain gaugemay be used and installed in the screw shanks and cable anchors torecord the actual current strain in the screw or cable during andfollowing installation and transmit it by radio frequency transmissionto an external reader. Power may be provided by magnetic induction froman external source. Thus, spring-screw or wire-cable tension inducedbone compression can be accurately set during installation and monitoredthroughout the healing process which can take months. Thereby earlydetection of compression outside the acceptable range and adjustment,correction or protection is feasible to prevent delayed healing andavoid complications.

By micro-adjusting tapped thread spacing to match a fully stressedcondition of screw and bone, with freeboard, i.e., gap where necessaryfor installation; a more uniform distribution of bone stress can beachieved and thereby higher pullout loads, while avoiding yield stressconcentrations of 60 N/mm² or above.

BRIEF DESCRIPTION OF THE DRAWINGS

While exemplary embodiments of the present technology have been shownand described in detail below, it will be clear to the person skilled inthe art that changes and modifications may be made without departingfrom its scope. As such, that which is set forth in the followingdescription and accompanying drawings is offered by way of illustrationonly and not as a limitation. The actual scope of the invention isintended to be defined by the following claims, along with the fullrange of equivalents to which such claims are entitled.

In addition, one of ordinary skill in the art will appreciate uponreading and understanding this disclosure that other variations for thetechnology described herein can be included within the scope of thepresent technology.

FIG. 1 is perspective view of a system including a shaft with a base ahead and springs;

FIG. 2 is an exploded perspective view of the system of FIG. 1;

FIG. 3 is an alternate exploded perspective view of the system of FIG.1;

FIG. 4 is a side view of the shaft of the of FIG. 1;

FIG. 5 is a perspective view of the base of FIG. 1;

FIG. 6 is an alternate perspective view of the base of FIG. 5;

FIG. 7 is a cross sectional side view of the base of FIG. 5;

FIG. 8 is a perspective view of the head of FIG. 1;

FIG. 9 is an alternate perspective view of the head of FIG. 8;

FIG. 10 is a cross sectional side view of the base of FIG. 8;

FIG. 11 is a perspective view of the spring of FIG. 1;

FIG. 12 is a side view of the spring of FIG. 11;

FIG. 13 is a cross sectional side view of the spring of FIG. 11;

FIG. 14 is a perspective view of an alternate embodiment of a systemwith the base, the shaft, and the springs of FIG. 1 with an alternatehead;

FIG. 15 is a perspective view of an alternate embodiment of a head ofFIG. 14;

FIG. 16 is an alternate perspective view of the head of FIG. 15;

FIG. 17 is a cross-sectional side view of an alternate embodiment screwwith a cup-like component with a springs, or washers, in anon-compressed position;

FIG. 18 is a cross-sectional side view of the screw of FIG. 17 with thesprings in a compressed position;

FIG. 19 is a side view of an alternate embodiment system, or screw,which may be specific to calcaneal repairs;

FIG. 20 is a side view of a fractured calcaneus with wire cables and thesystem of FIG. 19;

FIG. 21A is a partial cross-sectioned side view of a cable-screw systemwith the wire cables of FIG. 20 with the cable system dis-engaged withthe screw system;

FIG. 21B is a partial cross-sectioned side view of a cable-screw systemwith the wire cables of FIG. 21A with the cable system engaged with thescrew system;

FIG. 21C is a side view of an alternate embodiment of a wire cablesystem with two cable systems, one with springs and one without springs;

FIG. 21D is a side view of a wire cable system with two cable systemsconnected together;

FIG. 22 is a partially cross-sectioned side view of an alternateembodiment of the cable-screw system of FIG. 21;

FIG. 23 is a cross section view of a cable system of FIG. 20; and

FIG. 24 is a side view of multiple cable wire or cable screw systems ofFIGS. 21 and 22, engaging a fractured bone.

DETAILED DESCRIPTION

Micro movements occasioned by loose screws and twisted wires cause manyproblems including delayed non-union or pseudoarthrosis—formation of afalse joint caused by the failure of the bones to fuse.

It is contemplated that hardware loosening is largely due to necrosis,fissuring and resorption of fracture zone contact points and at hardwarecontact points. When a bone fractures, the surface of the fracture dies,which may be 15 microns deep on each side due to lack of blood. Cutosteotomy may result in greater damage to the cut surface due to theblade action and thereby more joint bone necrosis. When a joint bone isreduced for fixation, whether natural or cut, at the micro scale, thejoint bone only actually touches initially at a few small contactpoints. Screw landings and threads also initially bear on bone only atsmall contact points.

These small initial contact points, in the fracture zone and belowlandings and on top of screw threads, are locally highly stressed byhardware that is producing compression in the bone. The contact pointsfissure and are soon resorbed by the body. This early resorption resultsin progressive diminution of the fracture gap. Diminution is the gradual(2 to 24 hours) reduction in the physical dimension between fracturesurfaces. Tension in rigid hardware (used to create compression in a cutor natural osteotomy) is often reduced by diminution of a fracture gap.An orthopedic screw, installed through the fractured zone of the bone orthrough an osteotomy, stretches a few micros when it is tightened to aspecified torque. When diminution occurs in the zone of bone healing,the stretching relaxes and the installed force of tension in the screwis correspondingly relaxed. Further relaxation of hardware may resultfrom fissuring and resorption of small contact points under landings andon top of threads bearing on bone.

The proposed device, described herein, integrates a spring-like sectioninto screws and cables such that the hardware will retract and continueto provide the necessary pressure on the bone to hold fracture sitestogether. Internal fixation, using such spring loaded hardware, issecured against movement from internal and external forces, and can beoptimized to sustain compression specific to promoting bone growth. Thissustained compression may enable bone bridging, increased rates at whichthe bone will heal, decrease soft tissue damage from traditional screwlifting, and prevent additional injury, delayed union, nonunion, and/orinappropriate union. Furthermore, the current device, using such dynamichardware, fixation can more frequently be done internally, eliminatingexternal fixation sources for pin-tract infection.

One embodiment of the current device proposes configuring spring washersinto screws and cable connections to deliver the compressive forcenecessary to promote bone growth while retracting to close gaps andcontinue compressive force with flexibility to resist internal andexternal forces that may otherwise cause movement in the joint. Some ofthe current spring configurations also avoid unbalanced internalstiffness problems that could otherwise result in progressive or fatiguefailure under cyclic loading. As previously disclosed, a radio frequencycontrolled strain gauge may be installed in the screw shanks and cableanchors to record the actual current strain in the screw or cable duringand following installation and transmit it by radio frequencytransmission to an external reader for those reasons previouslydisclosed.

Referring to FIG. 1, a system 10, which may be a compression screw,includes a shaft 12, or shank, a base 14, head 16 and springs 18, orwashers or spring washers. The screw 10 may come pre-assembled or may bescrewed and pinged, press fitted or welded into place as a single piecepermanently assembled to prevent disassembly during installation, use orremoval.

Referring to FIGS. 2 and 3, the screw 10 includes a proximal portion 20which may include the base 14, the head 16, the springs 18 and aproximal end of the shaft 12. The screw 10 also includes a distalportion 22 which mainly comprises a distal end of the shaft 12. Thedistal portion 22 may include threads 24 which may be typical (bonescrew threads. A distal tip 26 of the shaft 12 may be a blunt end.

The shaft 12 of the screw 10 comprises a longitudinally extendingcylindrical body with a longitudinal axis. A proximal end 13 of theshaft 12 may comprise threads configured to engage the head 16, or screwhead. The base 14, or head base, may slidably engage the shaft 12 bysliding onto the shaft 12 at the proximal end 13. The springs 18 mayalso slidably engage the shaft 12 by sliding onto the shaft 12 at theproximal end 13. The head 16 may threadably engage the shaft bythreading onto the proximal end 13, of the shaft. The shaft 12 mayinclude a non-threaded portion between the distal portion 22 and theproximal end 13. The shaft 12 may also include a lip or shoulder betweenthe proximal end 13 and the distal portion 22. The lip or shoulder maybe configured to engage the base 14 to retain the base 14, springs 18and head 16 near the proximal end 13 of the shaft 12. However, a lip isnot necessary and the base 14 and springs 18 may slide along the entireshaft from the proximal end 13 to the distal portion 22.

Referring to FIG. 4, the shaft 12 is illustrated by itself with thethreaded distal portion 22 with the distal tip 26 and the threadedproximal end 13. The non-threaded portion between the distal portion 22and the proximal end 13 may be smooth. The threads 24 may extendradially and helically from the distal portion 22 of the body of theshaft 12 with threads 24 having a greater diameter than the main body ofthe shaft 12. The distal tip 26 may be a blunt end to provide greaterfixation within a bone tunnel or with the cortex of a bone with the helpof threads 24 may be full sized threads which may also aid insuccessfully grabbing and maintaining placement while the screw 10 iscompressed. The proximal end 13 may be smooth or tapered or may includeridges or barbs to engage the head, or base, of the proximal portion 24.

The proximal end 13 may be polygonal in shape instead of threaded andmay be a hexagon. A hexagonal shape may require a complementary fit inthe head 16 with a hexagonally shaped aperture in the head 16 to allowfor a press or snap fit. While a hexagonal shape may be ideal andprovide for an Allen wrench type of insertion and tightening method itwill be appreciated that any polygonal shape may work.

Referring to FIG. 5, the base 14 may be substantially disc shaped with afirst spring engagement surface 28, or upper surface, wherein the uppersurface 28 may be flat to allow the springs 18 to rest on the uppersurface 28. The base may also include a first aperture 30, which may becentral to the base 14, which may be substantially cylindrical, mayextend entirely through the body of the base and configured to receivethe proximal end 13 of the shaft 12. The first aperture 30 may slidablyreceive the proximal end 13 or may threadably receive the proximal end13 as well.

Referring to FIGS. 6-7, the base 14 also includes a bone engagementsurface 32, or bottom surface, wherein the bottom surface 32 may besomewhat convex in shape. The bottom surface 32 is configured to engagethe cortex of a bone. A portion of the bottom surface 32 nearest theaperture 30 may engage the lip of the shaft 12 as previously mentionedherein. The aperture 30 when engaged with the shaft 12 may be coaxialwith the longitudinal axis of the shaft 12. The base 14 diameter may belarger than the diameter of the shaft; however the diameter of the firstaperture 30 may be smaller than the diameter of the non-threaded portionextending between the proximal end 13 and the distal portion 22, thusallowing the base 14 to fit over the proximal end 13 but resting on thelip or shoulder, as previously disclosed, between the distal end and theportion extending between the proximal end 13 and distal portion 22.

Referring to FIGS. 8-10, the head 16 may be somewhat disc shaped andincludes a second spring engagement surface 34, or lower surface,wherein the lower surface 34 may be flat to allow the springs 18 toeasily engage the head 16. The disc shape of the head 16 may have agreater height than that of the base 14. A circumferential wall 40 mayextend from the lower surface 34 to a top surface 36 which may beslightly rounded or convex. The top surface 36 may include a void 38extending at least partially into the body of the head 16 toward thelower surface 34. The void 38 may be hexagonal in shape but may take onany polygonal shape configured to receive an insertion, installation ortightening instrument. The head 16 may also include a second aperture42, which may be central to the head, and substantially cylindrical. Thesecond aperture 42 may extend through the entire body of the head 16 andmay be threaded to engage the threads on the proximal end 13 of theshaft 12. However the second aperture 42 may be tapered or smooth or mayinclude ridges or barbs to engage an appropriate fit with the proximalend 13 of the shaft 12.

The diameter of the head 16 may be substantially similar to the diameterof the base 14. The second aperture 42 diameter may be substantiallysimilar to the diameter of the first aperture 30 and sufficient toengage the proximal end 13 of the shaft 12 in an appropriate mannereither through threads, taper, barbs, ridges of the like either bythreaded fit, snap fit, press fit or other means known in the art.

The head 16 may reversibly engage, by way of threading, press fit orother means, the proximal end 13 of the shaft or may non-reversiblyengage, by way of welding or other means, the proximal end 13 dependingon the engagement features. In the case of a taper or ridged engagementof the head 16 to the proximal end 13 it may engage by way of a snap fitor press fit or the like. Upon insertion of the head 16 onto proximalend 13 or upon engagement of the head 16 to the proximal end 13 thesecond aperture 42 may be coaxial with the longitudinal axis of theshaft 12.

Referring to FIGS. 11-13, a spring 18 may be substantially disc shapedwith a convex first portion 44 and a concave second portion 46. Theconvex first portion 44 may be on the upper side of the spring 18 andthe concave second portion 46 may be on the lower side of the spring 18.The first portion 44 and second portion 46 may be defined by acircumferential spring wall 48. The shape of the spring and the concaveand convex features are what provide the spring 18 compression byallowing the spring 18 to be manipulated to apply compression on thesystem 10. From a side view, the spring 18 may be somewhat trapezoidalin shape. The spring 18 may be a Belleville washer with the capacity todeliver compression to the system 10. The spring 18 may be combined witha plurality of springs 18 to effect interfragmentary gap reduction fromnatural resorption during healing, and maintain load sufficient tostabilize the fracture zone while avoiding pressure necrosis in a seatedscrew. It will compensate during the natural osteoclastic resorption byretraction without the loss of force necessary to continue promotion ofbone growth.

Referring to FIG. 12-13, the spring 18 may further include a thirdaperture 50, which may be central to the spring 18, which may extendthrough the entire body of the spring 18. Upon insertion of the spring18 onto proximal end 13 or upon engagement of the spring 18 to theproximal end 13, the third aperture 50 may be coaxial with thelongitudinal axis of the shaft 12. Multiple springs 18 (see FIGS. 1-3)may be stacked on top of each other to provide greater compressive forcein the system 10 and reduced screw loosening after the screw 10 isplaced in a bone. The number and orientation of the springs may varydepending on the compressional force need. For example, the height ofthe spring stack may be as low as 2.5 mm on a nominal 3 mm diameterscrew and provide adequate compression.

The diameter of the spring 18 may be substantially similar to thediameter of the head 16 and the base 14. The third aperture 50 diametermay be substantially similar to the diameter of the first aperture 30 orsecond aperture and sufficient to slidably engage the proximal end 13 ofthe shaft 12.

The installation of springs 18 from a proximal end prior to headinstallation enables springs 18 to maintain a small aperture 50 whichmay only be slightly larger than the shaft 12. The small aperture allowsfor increased spring compression and flexibility relative to springswith larger apertures required by traditional installation of springwashers over bone threads of distal portion 22. It is appreciated thatthe spring 18 may have an outside diameter no larger than that of thehead 16.

Assembly of the system 10 also allows for the relative small diameter ofthe third aperture 50 to the outside diameter of the washer 18 whichallows for greater compressive strength and flexibility of the system10. Assembly of the system 10 (and the other embodiments disclosedherein) may be done during operation to obtain different levels ofcompression or may be preassembled. One method of assembly may includesliding a threaded portion (disclosed in more detail herein) on to theshaft 12 from the proximal end 13 and being freely slidable along theshaft 12 from the distal portion 22 being unable to pass the distalportion because of the radially extending threads 24. The base 14 maythen slide onto the shaft from the proximal end 13 and also freely slidealong the shaft 12 until engaging the threaded portion. The spring 18,which may include a varying number of washers, may then slide onto theshaft, the washers 18 being inserted onto the shaft in either the samedirections or in alternating directions, or half in a first directionand half in a second direction. The washers may freely slide untilengaging the base 14. Finally a head 16 engages the shaft in any of themanners previously disclosed, threads, press fit, snap fit and preventswithdraw of the threaded portion, base 14 and spring 18. The slidableportions, upon insertion into bone, may all engage one another and sitadjacent to one another when fully engaged in the bone.

When the plurality of springs 18 are engaged with the system 10 thesprings 18 may all face the same direction, thus providing complementaryfit of the convex portions with the concave portions, with the concaveportions facing the base 14. However, the plurality of springs 18 mayalso be placed half in one direction—convex portion facing the base14—and half in the opposite direction—convex portion facing the head16—creating a spring void 219 (refer to FIG. 17) between the two halvesof the plurality of springs because of two concave portions facing oneanother. Alternatively the springs 18 may alternate in their assemblywith convex portions adjacent to one another and concave portionsadjacent to one another.

Referring to FIG. 14, an alternate embodiment of the system 110illustrates substantially similar features to the previous disclosedembodiment. An alternate embodiment head 116 is different than thepreviously disclosed head 16 in that the alternate embodiment head 116may be substantially hexagonal in shape. It will be appreciated thatmany alternate embodiments are possible for the shape and size of thebase 14 and that of springs 18 of proximal portion 20 in pursuit ofbetter approximating contours of the external dimensional envelope oftraditional screw heads while enabling the advantages of spring actionfor sustained force. This may include a smaller outside diameter of base14 and springs 18 that vary in outside diameter, thickness and springheight. The stack of springs 18 may vary from being smaller outsidediameter near the base 14 to a larger outside diameter as they residecloser to the upper portion of the spring stack 18.

Referring to FIGS. 15 and 16, the head 116 may include a circumferentialwall 140 substantially hexagonal in shape from a top view. The wall 140may extend from a lower surface 134 to a top surface 136. The lowersurface 134 is configured to engage the springs 18 of the system 110 andmay be flat. The top surface 136 may be relatively smooth and somewhatconvex or rounded extending form the wall 140 toward the top surface136. A bore 142 may extend entirely through the body of the head 116from a lower surface 134 and a top surface 136. The bore 142 may becentral to the head 116 and may include thread extending the length ofthe bore 142. The diameter of the head 116 may be smaller than thediameter of the springs 18 and/or the base 14. However, the diameter ofthe bore 142 may be substantially similar to the diameter of the firstaperture 30 and second aperture 42 and sufficient to engage the proximalend 13 of the shaft 12 in an appropriate manner either through threads,taper, barbs, ridges or the like either by threaded fit, snap fit, pressfit or other means known in the art.

It will be appreciated that the bore may not include threads and mayalternatively be tapered, comprise ridges or barbs or similar engagementfeatures to engage an appropriate fit with the same or similar, andperhaps complementary, features of the proximal end 13 of the shaft 12.Upon insertion of the head 116 onto proximal end 13 or upon engagementof the head 116 to the proximal end 13 the bore 142 may be coaxial withthe longitudinal axis of the shaft 12.

Referring to FIGS. 17-18, an alternate embodiment of a system 210 orscrew includes a cup 211 with a head 216, which may be similar to theprevious hexagonal head 116, springs 18, or washers, a shaft 212 with aproximal portion 220 and distal portion 222. Referring to FIG. 17, thecup 211 may slidably engage the shaft 212 and be manufactured ormachined separately from the screw 210 all-together. The cup 211includes a base 214 radially extending from the shaft 212 and the cup211 may include a central bore for allowing the shaft 212 to passthrough. The cup 211 includes a radially and longitudinally extendingwall 215 extending from the base 214 toward the proximal end 213. Thecup 211 may include a radial lip 217, or flange, at the proximal end ofthe cup 211.

The head 216 may engage the proximal end 213 of the shaft 212 by meanspreviously described herein for alternate embodiments. As shown in FIG.17, the head 216 may threadably engage the proximal end 213. As the head216 advances distally the head may compress the washers 18 thuseliminating the spring void 219 created, as described in paragraph[0081], compressing the springs 18 and tensioning the screw 210.

Referring to FIG. 17, the springs 18 may be retained by the cup 211 byslidably engaging the shaft 212 through the third aperture 50. Thesprings may rest on the base 214 of the cup 211. As previously describedthe springs may alternate in their engagement in the manner described inparagraph [0081].

The distal portion 222 of the shaft 212 may include threads 224. Adistal tip 226 of the shaft 212 may be a sharp, pointed tip and may beself-tapping. However, it will be appreciated that the distal tip 226may also be a blunt end similar to the previous embodiments describedherein. Distal to the cup, a threaded portion 230 may slidably engagethe shaft 212 and may slide freely along the shaft between the threads224 and the base 214 of the cup 211 until engaged in the bone. Thethreaded portion 224 may have threads which extend radially from acentral axis and the longitudinal axis of the shaft 212. The threads ofthe threaded portion 230 may have greater diameter than the threads 224of the distal portion 222.

The cup may transfer load from a tall stack of washers that may extendbelow the cortical bone to bear on cortical bone under the lip at thetop of the cup 211. Also, the interior surface of the cup top lip 217may include a hexagonal shape for installation of threaded portion 230,which may be bonded or integrally formed with the cup 211 bottom. Thethreaded portion 230 may add head bearing capacity in cancellous bone.

As is the case with all the embodiments disclosed herein, an electronicchip with a radio frequency tag 228 may be positioned within the body ofthe shaft 212.

The previously described embodiments cause continuous compressionbetween the near and far cortex of an osteotomy site. It allows forcontinued stability via compression, during weight bearing, tensions,moments and shears. The screw 10,110 provides dynamic compressioncontinuously during the bone healing phases which begins immediatelyupon fixation and can take weeks, to several months, to years to fullycomplete.

The screw 10,110 is designed with the spring for initial installation ata high load with relaxation from natural resorption such that the bonestate is in the compressive stress range for mechanically stabilizingthe joint while facilitating osteogenic stimulation of limitedintermittent mechanical loading—avoiding excessive rigidity. Theconfiguration can be fine-tuned to achieve total micro stretch requiredby all sources of bone resorption at max combined stress. Thickness,stack, orientation and deflection limiters of the current device can bevaried in this new construct to resist tension, shear, and torsion,which is more efficient delivering and sustaining value per unit of bonepurchase.

Spring screws stretch or shorten under tension or compressionrespectively. The amount varies according to the screw configuration,its material properties, the load, the screw orientation in bone, andthe bone properties. The amount is usually a few microns. But, due tothe differential stiffness of the resisting bone, the stretching can besignificant and redistribute induced load, effectively concentrating itto produce the progressive failure mode described previously. By cuttingin the wedge shaped gap above threads when tapping bone to receive ascrew, a more uniformly distributed load can be achieved. By engagingthe full bone bearing thread 24 simultaneously, significantly largerpull out values can be achieved relative to specific bone purchase.

The screw 10 components described, work in balance or harmony togetherand with the body's natural reaction to optimize bone healing, oftenenabling the body to shorten or skip usual phases of healing. Togetherthe elements facilitate installation at higher compressive forces,relative to its bone purchase, and dynamically close the fracture zoneor interfragmentary gap as it resorbs during the first few hours to daysafter rigid fixation, due to osteoclastic resorption. Fixation isdynamically retained, hospitable to osteoblastic formation for sustainedbone growth. The screw 10, 110 may not loosen, but may relax, calibratedfor natural resorption such that the Belleville washer springs 18 in therelaxed state produce bone compression in the ideal zone formechanically stabilizing the joint while facilitating osteogenicstimulation by limited intermittent mechanical loading—avoidingexcessive rigidity while restraining movement in the fracturedjoint—reducing attendant delay, or failure to heal.

An osteotomy or fracture placed under the dynamic stabilizing forces ofthe disclosed device, allows earlier motion and weight bearing typicalof earlier therapy and use—eliminating considerable muscle and boneatrophy, and loss of work time. Substantially reduced or eliminated willbe post-surgery, non-weight-bearing status, as well as possibly relatednon-compliance for extended periods of time.

Manufacture of the device may be accomplished by specific diameterspring washers, which may be in the range of 4 mm to 10 mm, beingstamped or milled from heat treated and or cold worked stainless steelusing dies milled from similar material. Other components can befabricated by rolling round wires or bars, or milling. Press fitting,threaded and micro-welding assembly may also be used.

Radio frequency tags may be used on an electronic chip and strain gaugewith power provided by a magnetic induction reception coil excited byexternally induced magnetic flux in close proximity to the installedtag. A hole is drilled in the spring shaft or cable anchor where the tagis inserted and anchored into place.

A surgeon may use the device to reduce the fractures or osteotomysite(s), whereupon the location for fixation screws, wire-cables,connections, bone plates, and buttons would be identified. Screwlocations would be drilled, measured with a depth gauge and tapped andrecessed to accommodate the selected screws. The fully assembled screwswould be threaded into the tap-threaded and recessed holes and securedfinger tight or to specified torsion or direct shank tension.

The sequence of screw, cable and other hardware installation andtensioning may be pre-determined. Accordingly, screw anchor hardwarewould be tensioned by rotating the screw head 16,116. Tensioning wouldproceed until proper toque is achieved to indicate design tension asbeen achieved in the shaft 12 and springs 18, or until the reading fromthe radio frequency tag-strain gauges indicates the predetermined propertension has been achieved, whereupon, further tensioning would cease.Following multiple hardware installations, actual tension reading isagain verified with the strain gauges and adjustments made, whereupon,the site would be surgically closed. The radio frequency tag-straingauges transmit strain readings when energized, at predeterminedintervals. Upon follow-up doctor visits, the stored data from theexternally worn energizer and recorder is reviewed and therebycontinuing tension levels verified. Automatic transmission via cellphone technology may also be utilized. Warning and transmission can betriggered by strain gauge sensing of strain above or below qualitystandards.

If necessary, the site can be reopened and the screws retightened orremoved. The radio frequency tag-strain gauges could be deactivatedpermanently when they are no longer needed.

Referring to FIGS. 19 and 20, an alternate embodiment may include two ormore components which allow for compression and tension. This embodimentmay be ideal for calcaneal fractures and is described further herein.

A system 310, or screw, may include two components or portions, a firstportion 336, or lower portion, which allows for bone compression,similar to the proximal portions 20 of the previous embodiment, system10, and a second portion 338, or upper portion which allows fortensioning and stretching the calcaneus bone to reestablish proper bonedimensions. The system 310 includes a first shaft 312, a second shaft314 and a compression rod 316. The first shaft 312 may comprise a firstbone threaded portion 318 toward a distal end, the threads beingaggressive enough to engage and secure the screw 310 in its appropriatelocation. A second bone threaded portion 320 spaced from the firstthreaded portion 318 may have more aggressive threads and may have alarger diameter than the first threaded portion to engage a softerportion of a bone. The second bone threaded portion 320 may be aseparate piece, integral with base 322 and freely slideable along thefirst shaft 312. A base 322 may engage the shaft proximal the secondthreaded portion 320 and is configured to allow the springs 18, orBelleville washers, to rest on the base 322, and to use for removal ofthe system if required. The base 322 may be similar to those previouslydescribed or may be a bearing nut. A third threaded portion, may bepositioned at a proximal end of the first shaft 312 and configured toengage the first shaft screw head 326 which is distal the compressionrod 316, wherein the first shaft screw head may be integral to thecompression rod 316 and engages the first shaft 312 by complementarythreads in the first shaft screw head 326.

A proximal end of the compression rod 316 may comprise rod threads 324to engage a compression rod head 328, which may be a head nut. The headnut 328 may include complementary threads to engage the threads of theproximal end of the compression rod 316. The compression rod head 328engages, or may be integrally formed with, the second shaft 314.

Proximal to the compression rod head 328, the second shaft 314 allowsfor springs 18, to rest on the compression rod head. Proximal to thesprings 18, a fourth threaded portion 330 is positioned, which may havea larger diameter then either the first 318 or second 320 threadedportions, and is sized with sufficient thread purchase to securestability in the soft interior bone of a calcaneus or other bone. Thefourth threaded portion 330 may be separate from the second shaft 314and may be freely slideable along the second shaft. The fourth threadedportion 330, or intermediate component, is mounted to, or slides on, thesecond shaft 314 and is secured by a securing nut 332, which may beintegral with and may be hexagonal in shape but any polygonal shape willdo. A complementary void in the third threaded portion 330 may bepositioned at its proximal end to slidably receive the securing nut 332.

Positioned at a proximal end of the second shaft 314, and the proximalend of the system 310, may be an installation nut 334 provided toinstall the entire system 310. The installation nut 334 may be hexagonalin shape but any polygonal shape is contemplated. The lower portion 336of the system 310 may be engaged by clockwise rotation and the uppersection 338 by counterclockwise rotation. It will be appreciated thatthe lengths of each of the first shaft 312, second shaft 314 andcompression rods 316 may all vary in length and diameter; however thesecond shaft 314 preferably has a single length with variations in thefirst shaft 312 and compression rod 316 being more common.

Referring to FIG. 20, the system 310 (multiple) is depicted within abone 402, which may be a calcaneus bone, with multiple fractures. Theadvantages of the screw 310 in conjunction with bone-compressionproducing wires 400 are to allow for fixation in a minimally invasivemethod. On at least one end, and maybe on both ends, of the wires 400,is a screw 410. Furthermore another medial-lateral device 404, which maybe a screw of wire cable assembly, may be used for securement of thefracture in a medial-lateral direction. Further depicted in FIG. 20 arezones of compression 403, directed toward the bone exterior. These zonesof compression 403 may require an internal head, rather than an externalhead.

Surgery for calcaneal fractures is ideally performed within the first6-8 hours following injury, before significant edema sets in. If thiscannot be accomplished in this time frame, the surgery is usuallyprolonged for 7-10 days until the edema subsides enough to allow forskin closure.

The screw 310 has two components that will allow for compression of thedistal portions while also providing an extension element proximally.This would ideally hold the fractures in a compressed environment toencourage healing while holding the bone out to the anatomic length asis achieved with existing art by a buttress plate. The bone-compressionproducing wires 400 can be placed laterally to medially to hold theposterior facet fragments and/or the calcaneocuboid articulationtogether while also being placed at other locations to reduce the widthand correct the varus component. These wires 400 and screws 310 can beplaced percutaneously which will reduce the need for the larger lateralextensile approach as well as reduce the need to prolong surgery untiledema reduces.

An alternate embodiment of a system 410 is depicted in FIGS. 21A and 21Bwith the compression producing wires 400 (which are further describedlater herein). A spring and head portion 433 may be positioned proximala wire cable portion 434 and connected via a socket nut 424 andtensioned by a coupling nut 426 which will be described further herein.

Similar to a portion of the screw 310 previously described herein, thesystem 410 includes a shaft 412, a base 414 integral with a bonethreaded portion 420, springs 18 proximal to the base 414, a head 416integral with the shaft 412 and proximal to the springs 18. The base 414is hexagonal shaped and integral with the bone threaded portion 420 andonly slideably engages shaft 412, including only slidably engagingthreads 422A and 422B. It is anticipated that rotating base 414 willrotationally install bone threaded portion 420, and thereby the head andspring or the head and no spring portion 433. This installation ispreparatory to being connected to the cable 400 via the wire cableportion 434 and tensioned by rotating coupling nut 426. Similar toprevious embodiments, the shaft 412 of the system 310 comprises alongitudinally extending cylindrical body with a longitudinal axis. Adistal end of the shaft 412 may comprise a hexagonal or other polygonalnut 424 and distal threads 422 just proximal and adjacent to the nut424. The base 414 and bone threaded portion 420 may slidably engage theshaft 412 by sliding onto the shaft 12 at the distal end. The springs 18may also slidably engage the shaft 412 by sliding onto the shaft 412 atthe distal end. The shaft 412 may include a non-threaded portion betweenthe distal threads 422 and the proximal head 416.

The bone threaded portion 420, integral with the base 414 may slidablyengage the shaft 412 and move freely along the shaft until engagingsprings 18. The bone threaded portion 420 may be positioned proximal toand integral with the base 414 and distal the springs 18 and the head416, proximal the springs 18. Alternatively the springs 18 may beeliminated and the head 416 may be positioned just proximal the bonethreaded portion 420 integral with the head 414 to create a head and nospring portion positioned proximal the wire cable portion 434 andconnected via a socket nut 424 and tensioned by a coupling nut 426 whichwill be described further herein. The separate threaded portion 420 mayhave a larger radial footprint than any of the base 414, head 416, orsprings 18, and with larger threads to engage the bone.

Distal to the base 414 are the distal threads 422 a of the spring andhead portion 433 and proximal threads 422 b of the wire cable portion434. Threaded between the distal threads 422 a and proximal threads 422b may be a coupling nut 426 with interior right and left hand threads.The distal thread 422 a and proximal threads 422 b may be oppositelythreaded on either side of the coupling nut 426 to couple the right andleft hand threads of 422 a, and 422 b respectively, and together allowfor advancement and tensioning of the system 410. An electronic chip 428with radio frequency tags may be positioned or embedded with the shaftof the proximal threads 422 b and will allow a user or surgeon todetermine the tension in the shaft 412 as previously described.

The distal threads 422 b may be integrally formed with a component 424,a nut connection member, which may be hexagonal in shape and configuredto engage a nut receiving portion 432, or box securement portion, of thewire cable portion 434. The nut receiving portion 432 may comprise acomplementary fit within a cylindrical outer wall of the wire cableportion; however any geometric cross-sectional shape of the outer wallmay suffice. The nut receiving portion 432 receiving the nut connectionmember 424 may be preassembled or assembled during operation. The nutreceiving portion 432 within the outer wall may include a shoulder 436to engage a proximal end 438 of the nut connection member 424 to preventwithdraw of the nut connection member 424 from the nut receiving portion432.

Distal to, and integrally formed with the nut receiving portion, is acable crimp 430 which may be configured to secure the cable(s) 400 tothe system 410 via the nut receiving portion 432 to the connectionmember 424 and thus to the proximal threads 422 b of the wire cableportion 434 via the coupling nut 426 coupling the wire cable portion 434to the spring and head portion 433. Crimping of the cable(s) 400 to thecable crimp 430 may be accomplished by any means known in the art.

It will be appreciated that the system 410 is modular and may bemanipulated in a variety of ways. For example referring to FIG. 21B acable anchor may not include a spring section 18. For another example,referring to FIG. 21C, a tensioning portion 431 may include, at itsproximal end, an assembly similar to that of the wire cable portion 434including a cable crimp 430 engaging, or integrally formed with, aspring or washer cage 440, with cables extending from the crimp 430.This alternate assembly may allow for a cable to encircle bone andattach to itself via the system 435 and provide cable tension andthereby circumferential bone compression. Longitudinal andcircumferential compression may be combined and general fracture zonestability may be provided as desired (refer to FIG. 24). Longitudinalbone compression and structural stability may be provided by acombination of cables and a spring and head portion 433 with anchorsystems 410 on one end FIG. 21A and a head without a spring portionanchor systems 410 on the other end FIG. 21B. Alternatively the alongitudinal cable may be anchored on both ends by anchor systems 410,each with spring and head portion 433 with the integrally formed cablecrimp 430 on each anchor system 410 with each spring and head portion433 engaging the cable between one another via the coupling nuts 426 aspreviously described.

Another alternate assembly embodiment may include two wire cableportions 434 coupled together via the coupling nut 426. Referring toFIG. 21D, the assembly may essentially comprise two cable crimps 430crimping cable(s) 400 and two nut receiving portions 432 with two nutconnection members 424 with two proximal threaded portions 422A,422Bcoupled together via the coupling nut 426. When used in conjunction withother and alternate systems disclosed herein (refer to FIG. 24), thisassembly may allow for a stable, minimally invasive, tensioned structureencircling the fractured bone that anatomically retains and threedimensionally compresses fractured bone fragments. Friction is inducedbetween the compressed, fractured bone fragments, creating with thetensioned structure a composite, stable shear and moment resistingsystem. Proper bone dimensions are retained and stabile resistance tointernal and external forces are enabled during the surgery to installit. The springs in the system sustain bone stability and compression,optimal for healing throughout the process.

Referring to FIG. 22, an alternate embodiment of a system 510 isillustrated. With many of the components similar to previously describedembodiments system 510 may use different springs 518 than those springs18, Belleville washers, as previously described but it will beappreciated that the springs 518 may be Belleville washers as well.While the illustrated embodiment depicts a wire cable portion 434engaged with a spring and head portion 533 it will be appreciated thatthe spring and head portion 533 may be stand alone and function similarto the previous spring and head portion 433 embodiments. Different thanthe previous embodiments a head 516 may be similar to the coupling nut426 to engage the spring and head portion 533 with a wire cable portion534. The spring and head portion 533 includes a first shaft 512extending away from the wire cable portion 434, the shaft 512 includinga longitudinal axis. A separate second shaft 514 with threads extendsfrom a nut 524 where the second shaft may threadably engage the head 516similar to the distal threads 422 a of the previous embodiment. The nut524 may be integrally formed with the first shaft 512 or may separatelysit within the shaft 512 and non-rotatably engage the shaft 512.

At a proximal end of the shaft may reside a shaft head 520 which mayextend radially from the shaft 512 forming a circumferential shoulderand bulbous head which may at least partially encircle the head 516within the shaft head 520. Positioned distal the shaft head 520 may be athreaded portion 522 which may slidably engage the shaft 512 and isfreely slidable along the shaft from the shaft head to distal threads(not shown, but which may resemble previously disclosed screw threads).Alternate springs 518 may be used to provide bone compression and mayextend longitudinally along the shaft body. The wire cable spring 518may perform the same or similar function as the previously disclosedsprings 18, Belleville washers. Many different wire cable springs arecontemplated including fine spring wire cable, with helical coiledspring sleeve, or a spring wire cable with rectangular strands.

Referring back to FIG. 22, the system 510 may closely depict the wirecable assembly shown in FIG. 20 with the wire cable(s) 400 extendingbetween two screws. The screws may be that spring and head portion 533as depicted here; however the screws may also be the assemblies of theprevious systems alternatively engaging the wire cable portion 434 in asimilar manner.

The wire cable portion 434 is substantially similar to the previouslydisclosed embodiment with the exception of a differing cable(s) 600extending from a wire crimp 530 which may be different from the previousembodiment because of a possible different wire assembly being used.Differing wire assemblies are disclosed further herein. The wire crimp530 may be smaller circumferentially depending on the wire configurationdesired. Similarly a nut 536 engages a nut receiving member 532 in muchthe same manner as the previously disclosed embodiment. Further the nutreceiving member 532 is integrally formed with the wire crimp 530;however, in this embodiment the nut receiving member may becircumferentially larger than the wire crimp 530, again depending on thewire configuration desired.

Different wire configurations are depicted in FIG. 23. A first wire 700is shown, which may be a twisted wire strand. Multiple first wires 700may be combined to form a wire strand 702 and woven into a flat wirecable 400 and depicted as disclosed previously. The wire cable(s) 400are smaller wires in a flat cable profile and provide additional bearingsurface to allow for greater load on the bone over a larger bearingsurface causing less stress at single points on the bone. Individuallarger wires 704 may be placed in a flat multi-wire cable configuration706 as well. Another possible wire configuration is a wavy plate cableconfiguration 708 which may reduce costs and evenly spread the load in acost-effective way.

It will be appreciated that the device and alternate embodiments hereinhave been contemplated for use as a stand-alone device; however it isanticipated that the device may also be used in bone plates, inconjunction with external fixation rigs, in spine applications as wellas osteoporotic bone.

Referring to FIG. 24, a cable system assembly is illustrated across amultiple fracture 1010 bone 1000 with multiple cross sections. Multiplescrews or systems may be used to stabilize the fracture in alongitudinal direction along with multiple wire cable assemblies tocircumferentially surround the fractured bone by using cable attachmentassemblies as previously disclosed for alternate systems 410. The screws910 that may be used may be any of the previously disclosed embodiments,410, engaged with the cable(s) 400. The use of multiple longitudinalconstructs with compression screws 910 using cable(s) 400, combined withcircumferential cable systems 410, using cable(s) 400 provide for animmediate stable, minimally invasive, tensioned composite structure ofthe fractured bone leading to shorter recovery time and even immediateweight bearing.

The components disclosed herein may be made from titanium, stainlesssteel, or cobalt chrome. Other contemplates materials include graphitefiber reinforced non-biodegradable plastics to achieve reduced bonepurchase, metals, polymers, ceramics, glasses, composite materials,biological materials or tissues, or other biocompatible materials.Different materials may be used for individual components. Differentmaterials may be combined in a single component.

It should be understood that the present system, kits, apparatuses, andmethods are not intended to be limited to the particular formsdisclosed. Rather, they are to cover all combinations, modifications,equivalents, and alternatives falling within the scope of the claims.

The claims are not to be interpreted as including means-plus- orstep-plus-function limitations, unless such a limitation is explicitlyrecited in a given claim using the phrase(s) “means for” or “step for,”respectively.

The term “coupled” is defined as connected, although not necessarilydirectly, and not necessarily mechanically.

The use of the word “a” or “an” when used in conjunction with the term“comprising” in the claims and/or the specification may mean “one,” butit is also consistent with the meaning of “one or more” or “at leastone.” The term “about” means, in general, the stated value plus or minus5%. The use of the term “or” in the claims is used to mean “and/or”unless explicitly indicated to refer to alternatives only or thealternative are mutually exclusive, although the disclosure supports adefinition that refers to only alternatives and “and/or.”

The terms “comprise” (and any form of comprise, such as “comprises” and“comprising”), “have” (and any form of have, such as “has” and“having”), “include” (and any form of include, such as “includes” and“including”) and “contain” (and any form of contain, such as “contains”and “containing”) are open-ended linking verbs. As a result, a method ordevice that “comprises,” “has,” “includes” or “contains” one or moresteps or elements, possesses those one or more steps or elements, but isnot limited to possessing only those one or more elements. Likewise, astep of a method or an element of a device that “comprises,” “has,”“includes” or “contains” one or more features, possesses those one ormore features, but is not limited to possessing only those one or morefeatures. Furthermore, a device or structure that is configured in acertain way is configured in at least that way, but may also beconfigured in ways that are not listed.

In the foregoing Detailed Description, various features are groupedtogether in several embodiments for the purpose of streamlining thedisclosure. This method of disclosure is not to be interpreted asreflecting an intention that the embodiments of the invention requiremore features than are expressly recited in each claim. Rather, as thefollowing claims reflect, inventive subject matter lies in less than allfeatures of a single disclosed embodiment. Thus, the following claimsare hereby incorporated into the Detailed Description, with each claimstanding on its own as a separate embodiment.

1. A system comprising: a body comprising a shaft extending between aproximal portion and a distal portion; wherein the proximal portioncomprises a base and a head, wherein the proximal portion is configuredto hold a spring between the base and the head, wherein both the baseand the head each have a spring engaging surface; wherein the base andhead have a larger diameter than the shaft portion; wherein the basecomprises a bone engaging surface opposite the base spring engagingsurface.
 2. The system of claim 1, wherein the distal portion comprisesa blunt distal tip.
 3. The system of claim 1, wherein the base comprisesa bore, wherein the base slidably engages the shaft, the shaft at leastpartially passing through the bore.
 4. The system of claim 1, whereinthe base extends radially from and is freely slidable along the shaft.5. The system of claim 1, wherein the spring comprises a Bellevillewasher.
 6. The system of claim 1, wherein the spring comprises aplurality of Belleville washers.
 7. The system of claim 6, wherein theplurality of Belleville washers face the same direction.
 8. The systemof claim 1, wherein the head comprises a bore configured to threadablyengage a proximal end of the body, the head further comprising apolygonal shape configured to engage an insertion tool.
 9. A systemcomprising: a first portion and a second portion proximal to the firstportion, the first portion comprising a first shaft extending between afirst proximal portion and a first distal portion; wherein the firstproximal portion comprises a first base and a first head, wherein thefirst proximal portion is configured to hold a spring between the firstbase and the first head, wherein both the first base and the first headeach have a spring engaging surface; wherein the first base and firsthead have a larger diameter than the shaft portion; and wherein thesecond portion comprises a second shaft extending between a secondproximal portion and a second distal portion, wherein the secondproximal portion comprises a second base, an intermediate component anda second head, wherein the second distal portion is configured to hold aspring between the second base and an intermediate component, whereinboth the second base and the intermediate component each comprise aspring engaging surface; wherein the second head is proximal theintermediate component.
 10. The system of claim 9, further comprising arod engaged with and between the first portion and the second portion.11. The system of claim 9, wherein the intermediate component comprisesexternal threads.
 12. The system of claim 9, wherein the first andsecond bases each extend radially from the first and second shaftsrespectively and threadably engage the first and second shaftsrespectively.
 13. The system of claim 9, wherein the spring comprises aBelleville washer.
 14. The system of claim 9, wherein the springcomprises a plurality of Belleville washers.
 15. The system of claim 14,wherein at least a portion of the Belleville washers face differentdirections.
 16. The system of claim 9, wherein the first head and thesecond head are each hexagonal and comprise a bore configured tothreadably engage proximal ends of the first and second shaftsrespectively.
 17. A method of assembling a system comprising: engaging abase to a body of a screw by sliding the base onto the body of the screwfrom a proximal end of the screw toward a distal end of the screw,wherein the body comprises a shaft extending between a proximal portionand a distal portion, wherein the distal portion comprises threadsextending radially from the shaft, the distal portion further comprisingthe distal end; engaging a spring onto the body of the screw by slidingthe spring from the proximal end toward the distal end; positioning thespring proximal to the base; positioning a head proximal to the springs;engaging the head to the proximal end wherein the proximal end comprisesthreads recessed into the body, wherein the proximal end and the headcomprise complementary threads.
 18. The method of claim 17, furthercomprising advancing the base toward the distal end, wherein the basecomprises a bore, wherein the base slidably engages the shaft, the shaftat least partially passing through the bore.
 19. The method of claim 18,further comprising advancing the spring toward the distal end until thespring engages the base, wherein the spring comprises a plurality ofBelleville washers.
 20. The method of claim 19, further comprisingadvancing the head toward the distal end until the head engages thespring, wherein the head comprises a threaded bore and the proximal endcomprises recessed threads wherein the threaded bore is configured tothreadably engage the proximal end of the body.